Bayer application for regulatory approval of Aflibercept 8 mg accepted in China

At week 48 in the PULSAR clinical trial, aflibercept 8 mg, dosed with extended treatment intervals (every 12 or every 16 weeks) demonstrated comparable visual acuity to the standard of care Eylea (aflibercept 2 mg) with a fixed 8-week treatment interval, following three initial monthly doses. Aflibercept 8 mg showed unprecedented durability with 77% of nAMD patients randomized to the 16-week dosing arm achieving and maintaining 16-week treatment intervals with an average of only 5 injections through week 48. Of those nAMD patients randomized to the aflibercept 8 mg 12-week dosing arm, 79% maintained their interval with an average of 6 injections through week 48. In addition, aflibercept 8 mg showed faster fluid control to the comparator Eylea (aflibercept 2 mg) through to week 48.

The safety of aflibercept 8 mg was similar to the well-established safety profile of Eylea (aflibercept 2 mg) and consistent with previous clinical trials. The rates of intraocular inflammation and intraocular pressure increase for aflibercept 8 mg were low and similar to Eylea (aflibercept 2 mg). There were no cases of endophthalmitis, retinal vasculitis and no new safety signals through to week 48.

Eylea HD (aflibercept 8 mg) has been approved for use by the FDA in August 2023. To date, Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) has been approved in the EU, Japan and other markets for the treatment of nAMD and DME. Bayer has submitted regulatory applications for aflibercept 8 mg in additional markets.

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg following any regulatory approvals.